Non-invasive Brain Stimulation in Huntington's Disease

NCT04429230 | Unknown

• 1 other identifier: 115632
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Huntington's disease is a disabling neurodegenerative disease. Patients present with involuntary movements of the body and cognitive symptoms like behavioral problem, difficulty in planning tasks, etc. No effective treatment is currently available for them apart from symptomatic therapy. Currently, studies are going on the effectiveness of noninvasive brain stimulation (NIBS) in neurodegenerative diseases. It is a mode of brain stimulation technique where current is delivered into the brain by placing electrodes into their scalp. Transcranial pulsed current stimulation (tPCS) is a new modality of noninvasive brain stimulation. It is a device that generates electrical impulses. The current generated from this device can stimulate underlying brain areas. The investigators have planned to study the feasibility of non-invasive brain stimulation via tPCS in these patients of Huntington's disease. At first, the investigators will rate their involuntary body movement by a standard scale, assess arm movements by a robotic device, assess speech with standard protocol, assess brain electrophysiology by electroencephalography (EEG) and will also do gait (walking) analysis. Next, the investigators will give them 2 week (20 min/day) stimulation via real tPCS (active stimulation) or placebo (sham stimulation). After 2 weeks of stimulation, the investigators will re-assess the patient using the same tools mentioned pre-stimulation. Each patient will receive real and placebo stimulation with a 1-month gap in between. They will not know whether they are receiving real stimulation or placebo. Assessment will be done before stimulation, after 2 week real stimulation and after 2 week sham stimulation.

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (4)

• Feasibility of recruitment

  Can we recruit 15 HD patients for non-invasive brain stimulation study

  1 year

• Feasibility of finishing the study

  Can 15 participants finish the study

  1 year

• Feasibility of home based stimulation

  Can non-invasive brain stimulation in the form of transcranial pulsed current stimulation (tPCS) be appropriately applied at home

  1 year

• Feasibility of network targeting

  Can dysfunctional brain area in HD be targeted for stimulation non-invasively, using qEEG as a guide

  1 year

Secondary Outcomes (5)

• Change in UHDRS

  3 months

• Changes in spatiotemporal gait measures using objective gait analysis

  3 months

• Change in upper limb movements

  3 months

• Change in speech

  3 months

• Changes in Network fragmentation using Quantitative EEG

  3 months

Study Arms (2)

Real tPCS

ACTIVE COMPARATOR

Patients of Huntington's disease will be randomly allocated into both the arms. Real tPCS arm will receive active tPCS. Then they will be crossed over to Sham tPCS arm.

Device: Active Transcranial pulsed current stimulation (tPCS)

Sham tPCS

SHAM COMPARATOR

Patients of Huntington's disease will be randomly allocated into both the arms. Sham tPCS arm will receive sham tPCS. Then they will be crossed over to Real tPCS arm.

Device: Sham Transcranial pulsed current stimulation (tPCS)

Interventions

Active Transcranial pulsed current stimulation (tPCS) DEVICE

Active tPCS will be delivered through a pair of saline soaked (0.9% NaCl) surface sponge electrodes. Anodal stimulation will be given to brain area based on qEEG findings

Real tPCS

Sham Transcranial pulsed current stimulation (tPCS) DEVICE

Electrode placement will be the same as active stimulation but the electric current will be ramped down 5 seconds after the beginning of the stimulation to make this condition indistinguishable from the experimental active stimulation.

Sham tPCS

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of Huntington's disease diagnosed clinically or genetically proved

You may not qualify if:

• Patients who can't walk even with support, like wheel chair bound patients.
• Patients having other issues like stroke that can aggravate speech/ gait.
• Patients who are not able to provide informed consent.
• Patients who are unable to communicate by speech and who can't comprehend the English language.

Sponsors & Collaborators

• Western University, Canada: lead

Related Publications (2)

• Eddy CM, Shapiro K, Clouter A, Hansen PC, Rickards HE. Transcranial direct current stimulation can enhance working memory in Huntington's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jul 3;77:75-82. doi: 10.1016/j.pnpbp.2017.04.002. Epub 2017 Apr 5.

  PMID: 28390970 BACKGROUND

• Berardelli A, Suppa A. Noninvasive brain stimulation in Huntington's disease. Handb Clin Neurol. 2013;116:555-60. doi: 10.1016/B978-0-444-53497-2.00044-9.

  PMID: 24112923 BACKGROUND

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mandar S Jog

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandar S Jog

CONTACT

5196676708; Mandar.Jog@lhsc.on.ca

Jacky Ganguly

CONTACT

jganguly@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: June 12, 2020
• Study Start: September 7, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-08